New Painkiller Warning: What Does It Mean For You?

Ten years ago, the Food and Drug Administration (FDA) warned that the widely used nonaspirin painkillers ibuprofen and naproxen — including over-the-counter brands such as Advil, Motrin and Aleve — may increase the risk of heart attack and stroke. But new evidence has convinced the agency that the warning on these nonsteroidal anti-inflammatory drugs (NSAIDs) needs to be tougher. The FDA is now strengthening the wording to say that NSAIDs increase the chance of a heart attack or stroke, even …

FDA to Food Industry: Get Rid of Those Trans Fats

Artificial trans fats have helped the food industry since the 1950s enhance all kinds of not-so-healthy processed food; the artery-clogging fats have also contributed for decades to the country’s No. 1 cause of death — heart disease. On Tuesday, the Food and Drug Administration finally put a plan in place to ban trans fats from food — an anticlimactic move considering most food companies have reduced or eliminated trans fats thanks to a decade or more of pressure from health …

Two New Cholesterol Drugs Get Advisory OK, Despite Doubts

A federal advisory panel has recommended that two powerful new cholesterol-lowering drugs be approved by the Food and Drug Administration, despite concerns that the drugs’ long-term effects are still being studied. The medications belong to a new class of biotech drugs that lower cholesterol in a different, more powerful way than statins, which have been the standard treatment to protect against heart disease for the past 20-plus years. Called PCSK9 inhibitors, they’re taken by injection every two to four weeks …

‘Women’s Viagra’ Gets OK From FDA Committee

The first drug designed to boost a woman’s sex drive was given the green light Thursday by a government advisory panel, which recommended that the pill be approved by the Food and Drug Administration, but only with certain safety restrictions. The committee voted 18-6 in favor of approving the pill flibanserin for women on the condition that drugmaker Sprout Pharmaceuticals take measures to reduce the risk of its side effects. The FDA is expected to announce a final decision by …

Historic FDA Approval May Help Lower Drug Costs

AARP applauds the FDA’s approval of the first biosimilar prescription drug product in the U.S. It is a welcome step toward a workable approval process that will provide consumers with much-needed access to safe, effective biosimilar drugs, as envisioned by the Biologics Price Competition and Innovation Act in the Affordable Care Act. Today’s announcement marks the beginning of what AARP hopes will be a robust market that will offer consumers access to lower-cost alternatives to very expensive biologic medicines, such as those …

New FDA Warning About Testosterone and Aging Men

The Food and Drug Administration has a message for older men: Just because your testosterone level has dipped as you age doesn’t mean you need to take testosterone replacement drugs. In fact, the drugs could increase your risk of heart problems. In a new statement, the agency warned about overuse of the popular “low T” drugs to relieve symptoms in men who have low testosterone “for no apparent reason other than aging.” The FDA cautioned doctors about prescribing the medications inappropriately …